Recall Z-2766-2017— Medtronic Perfusion Systems
Class II · Terminated
Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2017-06-22, terminated 2020-07-22. It names one FDA 510(k) clearance: K831591. Product: DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring for up to six hours. Reason: Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected..
- Recalling firm
- Medtronic Perfusion Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-22
- Terminated
- 2020-07-22
- Firm location
- Brooklyn Park, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring for up to six hours
Reason for recall
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Data sourced from openFDA. This site is unofficial and independent of the FDA.